| Class 2 Device Recall SmartSite Low Sorbing Infusion Set | |
Date Initiated by Firm | August 30, 2013 |
Date Posted | September 26, 2013 |
Recall Status1 |
Terminated 3 on October 28, 2013 |
Recall Number | Z-2279-2013 |
Recall Event ID |
66150 |
510(K)Number | K931550 |
Product Classification |
Set, administration, intravascular - Product Code FPA
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Product | SmartSite Low Sorbing Infusion Set, Model#72313E
The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors. |
Code Information |
Lot Number 13016314 |
Recalling Firm/ Manufacturer |
CareFusion 303, Inc. 10020 Pacific Mesa Blvd San Diego CA 92121-4386
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For Additional Information Contact | 858-617-4000 |
Manufacturer Reason for Recall | CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number
13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron
filter (blue color) but a 0.2 micron filter (clear color) may have been added instead. |
FDA Determined Cause 2 | Employee error |
Action | CareFusion sent an Urgent Medical Device Recall Notification dated August 30, 2013, to all affected customers. The letter informed the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers were instructed to immediately check their inventory for the affected product, if any affected product is encountered, customers were instructed not to use. Customers were instructed to complete the customer response form and return the form to CareFusion with the affected product for replacement.. A distributor letter was also sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors were instructed to contact the Customer Support Team, return customer response form, and if they have questions then they were instructed to contact the CareFusion Support Center at 1-800-562-6018.
For questions regarding this recall call 858-617-4000. |
Quantity in Commerce | 600 units |
Distribution | CA, FL, AZ, and TN |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FPA
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